NeuroBo Pharmaceuticals Completes Last Patient Last Visit in Its Phase 2a Clinical Trial Evaluating DA-1241 for the Treatment of MASH
NeuroBo Pharmaceuticals has completed the last patient visit in its Phase 2a clinical trial of DA-1241, a GPR119 agonist for treating metabolic dysfunction-associated steatohepatitis (MASH). The trial consists of two parts: Part 1 comparing DA-1241 to placebo, and Part 2 testing DA-1241 combined with sitagliptin. Of 109 randomized patients, 95 completed the 16-week dosing period. The study's primary endpoint is measuring change in ALT levels at Week 16, with topline data expected in December 2024. The drug showed good tolerability in previous Phase 1 studies with healthy volunteers and type 2 diabetes patients.
NeuroBo Pharmaceuticals ha completato l'ultimo incontro con i pazienti nel suo trial clinico di fase 2a per DA-1241, un agonista del GPR119 per il trattamento della steatoepatite non alcolica associata a disfunzione metabolica (MASH). Lo studio è composto da due parti: Parte 1 che confronta DA-1241 con placebo, e Parte 2 che testa DA-1241 combinato con sitagliptin. Su 109 pazienti randomizzati, 95 hanno completato il periodo di somministrazione di 16 settimane. L'obiettivo primario dello studio è misurare il cambiamento nei livelli di ALT alla Settimana 16, con i dati preliminari attesi per dicembre 2024. Il farmaco ha mostrato una buona tollerabilità in precedenti studi di fase 1 con volontari sani e pazienti affetti da diabete di tipo 2.
NeuroBo Pharmaceuticals ha completado la última visita de pacientes en su ensayo clínico de fase 2a de DA-1241, un agonista de GPR119 para el tratamiento de la esteatohepatitis relacionada con disfunción metabólica (MASH). El ensayo consta de dos partes: Parte 1 que compara DA-1241 con placebo, y Parte 2 que prueba DA-1241 combinado con sitagliptina. De 109 pacientes aleatorizados, 95 completaron el periodo de dosificación de 16 semanas. El objetivo primario del estudio es medir el cambio en los niveles de ALT a la Semana 16, con datos preliminares esperados para diciembre de 2024. El fármaco mostró buena tolerabilidad en estudios previos de fase 1 con voluntarios sanos y pacientes con diabetes tipo 2.
NeuroBo Pharmaceuticals는 대사 기능 장애와 관련된 지방간염(MASH) 치료를 위한 GPR119 작용제인 DA-1241의 2a 임상 시험에서 마지막 환자 방문을 완료했습니다. 이 시험은 두 부분으로 구성되어 있습니다: 1부는 DA-1241과 위약을 비교하고, 2부는 DA-1241과 시타글립틴의 병용 요법을 시험합니다. 109명의 무작위 배정된 환자 중 95명이 16주 투약 기간을 완료했습니다. 연구의 주요 목표는 16주차에 ALT 수치의 변화를 측정하는 것이며, 2024년 12월에 초기 데이터가 예상됩니다. 이 약물은 건강한 자원봉사자 및 제2형 당뇨병 환자를 대상으로 한 이전 1상 연구에서 좋은 내약성을 보여주었습니다.
NeuroBo Pharmaceuticals a terminé la dernière visite des patients dans son essai clinique de phase 2a pour DA-1241, un agoniste du GPR119 destiné au traitement de la stéatohépatite associée à une dysfonction métabolique (MASH). L'essai se compose de deux parties : la Partie 1 compare DA-1241 au placebo, et la Partie 2 teste DA-1241 en association avec le sitagliptine. Parmi 109 patients randomisés, 95 ont complété la période de traitement de 16 semaines. L'objectif principal de l'étude est de mesurer le changement des niveaux d'ALT à la semaine 16, avec des données préliminaires attendues en décembre 2024. Le médicament a montré une bonne tolérance dans des études de phase 1 précédentes avec des volontaires en bonne santé et des patients atteints de diabète de type 2.
NeuroBo Pharmaceuticals hat den letzten Patientenbesuch in seiner Phase-2a-Studie für DA-1241, einen GPR119-Agonisten zur Behandlung der mit metabolischer Dysfunktion assoziierten Steatohepatitis (MASH), abgeschlossen. Die Studie besteht aus zwei Teilen: Teil 1 vergleicht DA-1241 mit Placebo, und Teil 2 testet DA-1241 in Kombination mit Sitagliptin. Von 109 randomisierten Patienten haben 95 den 16-wöchigen Dosierungszeitraum abgeschlossen. Primäres Ziel der Studie ist die Messung der Veränderung der ALT-Spiegel in Woche 16, wobei die Ergebnisse im Dezember 2024 erwartet werden. Das Medikament zeigte in früheren Phase-1-Studien mit gesunden Freiwilligen und Patienten mit Typ-2-Diabetes eine gute Verträglichkeit.
- High patient completion rate with 95 out of 109 patients finishing the dosing regimen
- Previous Phase 1 study demonstrated good tolerability in both healthy volunteers and T2DM patients
- Trial completion on track with topline data expected in December 2024
- None.
Insights
The completion of patient dosing in NeuroBo's Phase 2a trial for DA-1241 represents a significant milestone in MASH therapeutics development. The trial's dual-part design, investigating both standalone DA-1241 and its combination with sitagliptin, is particularly noteworthy. With 109 patients randomized and 95 completing the dosing, the study has maintained a solid
The trial's focus on ALT levels as the primary endpoint is a validated approach for assessing MASH treatment efficacy. The comprehensive secondary endpoints, including lipid profile changes, will provide valuable insights into the drug's broader metabolic effects. The previous Phase 1 results showing good tolerability in both healthy subjects and T2DM patients suggest a promising safety profile, though the upcoming data will be important for confirming therapeutic potential.
Topline Data Readout From Part 1 and Part 2 Expected in December 2024
"Completion of patient dosing in the Phase 2a clinical trial of DA-1241, in patients with presumed MASH, marks an important milestone for this promising cardiometabolic asset, bringing us one step closer to the topline data readout from both Part 1 and Part 2 of the Phase 2a clinical trial expected in December of this year," stated Hyung Heon Kim, President and Chief Executive Officer of NeuroBo. "As a reminder, Part 1 of this Phase 2a trial is exploring DA-1241 compared to placebo, while Part 2 is investigating the efficacy of DA-1241 in combination with sitagliptin, a DPP-4 inhibitor, which we believe will show synergistic effects compared to DA-1241, alone. In a previously reported Phase 1 study, DA-1241 was well tolerated in both healthy volunteers and individuals diagnosed with type 2 diabetes mellitus (T2DM). Based on the pre-clinical and clinical evidence, we maintain our belief that the distinctive mechanism of action DA-1241, which addresses the inflammation linked to MASH, will result in a safe and effective therapeutic option for this disease."
Each of the two parts of the Phase 2a trial of DA-1241 are designed to be 16-week, multicenter, randomized, double-blind, placebo-controlled, parallel clinical studies to evaluate the efficacy and safety of DA-1241 in subjects with presumed MASH. A total of 109 patients were randomized, while 95 patients completed the dosing. These patients were enrolled in either Part 1, which is exploring the efficacy of DA-1241 versus placebo, and randomized in a 1:2:1 ratio into 3 treatment groups: DA-1241 50 mg, DA-1241 100 mg or placebo, or into Part 2, which is exploring the efficacy of DA-1241 in combination with sitagliptin versus placebo, randomized in a 2:1 ratio into 2 treatment groups: DA-1241 100 mg/sitagliptin 100 mg or placebo.
For both Part 1 and Part 2, the primary endpoint is the change from baseline in alanine transaminase (ALT) levels at Week 16. Secondary efficacy endpoints include the proportion of subjects with normalization of ALT, absolute change in total cholesterol, low and high-density lipoprotein cholesterol, triglycerides, and free fatty acids from baseline, among others. Safety will be evaluated by monitoring adverse events (AEs) and serious adverse events (SAEs) leading to discontinuation and laboratory abnormalities.
For more information on this clinical trial, please visit: www.clinicaltrials.gov NCT06054815.
About DA-1241
DA-1241 is a novel G-Protein-Coupled Receptor 119 (GPR119) agonist with development optionality as a standalone and/or combination therapy for both MASH and type 2 diabetes (T2D). Agonism of GPR119 in the gut promotes the release of key gut peptides GLP-1, GIP, and PYY. These peptides play a further role in glucose metabolism, lipid metabolism and weight loss. DA-1241 has beneficial effects on glucose, lipid profile and liver inflammation, supported by potential efficacy demonstrated during in vivo preclinical studies. The therapeutic potential of DA-1241 has been demonstrated in multiple pre-clinical animal models of MASH and T2D where DA-1241 reduced hepatic steatosis, inflammation, fibrosis, and improved glucose control. Furthermore, in Phase 1a and 1b trials, DA-1241 was well tolerated in both healthy volunteers and those with T2DM.
About NeuroBo Pharmaceuticals
NeuroBo Pharmaceuticals, Inc. is a clinical-stage biotechnology company focused on transforming cardiometabolic diseases. The company is currently developing DA-1726 for the treatment of obesity, and is developing DA-1241 for the treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH). DA-1726 is a novel oxyntomodulin (OXM) analogue that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR) dual agonist. OXM is a naturally-occurring gut hormone that activates GLP1R and GCGR, thereby decreasing food intake while increasing energy expenditure, thus potentially resulting in superior body weight loss compared to selective GLP1R agonists. DA-1241 is a novel G-protein-coupled receptor 119 (GPR119) agonist that promotes the release of key gut peptides GLP-1, GIP, and PYY. In pre-clinical studies, DA-1241 demonstrated a positive effect on liver inflammation, lipid metabolism, weight loss, and glucose metabolism, reducing hepatic steatosis, hepatic inflammation, and liver fibrosis, while also improving glucose control.
For more information, please visit www.neurobopharma.com.
Forward Looking Statements
Certain statements in this press release may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "believes", "expects", "anticipates", "may", "will", "should", "seeks", "approximately", "potential", "intends", "projects," "plans", "estimates" or the negative of these words or other comparable terminology (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this press release, including, without limitation, those risks associated with NeuroBo's ability to execute on its commercial strategy; the timeline for regulatory submissions; the ability to obtain regulatory approval through the development steps of NeuroBo's current and future product candidates; the ability to realize the benefits of the license agreement with Dong-A ST Co. Ltd., including the impact on future financial and operating results of NeuroBo; the cooperation of NeuroBo's contract manufacturers, clinical study partners and others involved in the development of NeuroBo's current and future product candidates; potential negative interactions between NeuroBo's product candidates and any other products with which they are combined for treatment; NeuroBo's ability to initiate and complete clinical trials on a timely basis; NeuroBo's ability to recruit subjects for its clinical trials; whether NeuroBo receives results from NeuroBo's clinical trials that are consistent with the results of pre-clinical and previous clinical trials; impact of costs related to the license agreement, known and unknown, including costs of any litigation or regulatory actions relating to the license agreement; the effects of changes in applicable laws or regulations; the effects of changes to NeuroBo's stock price on the terms of the license agreement and any future fundraising; and other risks and uncertainties described in NeuroBo's filings with the Securities and Exchange Commission, including NeuroBo's most recent Annual Report on Form 10-K. Forward-looking statements speak only as of the date when made. NeuroBo does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
Contacts:
NeuroBo Pharmaceuticals, Inc.
Marshall H. Woodworth
Chief Financial Officer
+1-857-299-1033
marshall.woodworth@neurobopharma.com
Rx Communications Group
Michael Miller
+1-917-633-6086
mmiller@rxir.com
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SOURCE NeuroBo Pharmaceuticals, Inc.
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